Job Overview Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. Summary Of Responsibilities Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review. Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management. Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs. Provide training and guidance to the case processing team on medical aspects of case processing, only after a tenure of 1 year. Performs aggregate and signal analysis activities, as required in support of single case processing. Creates, maintains, and assumes accountability for a culture of high customer service. Qualifications (Minimum Required) Registered Nurse Minimum 2 years clinical and patient-facing experience, preferably from a tertiary or secondary hospital Physical Demands/Work Environment Office or home-based environment, as requested by the line manager. Learn more about our EEO & Accommodations request here. Show more Show less